Executive Summary. S32 Transplantation Volume 91, Number 11S, June 15, 2011

Transcription

1 S32 Transplantation Volume 91, Number 11S, June 15, 2011 Executive Summary PREAMBLE In response to the global disparities in access to transplantation, a growing demand for organs, and the self-evident harms of transplant tourism, a meeting of 140 representatives of international scientific and medical bodies, government officials, and ethicists was held in Madrid, Spain, on March 23 to 25, This Third Global Consultation was organized by the WHO, TTS and ONT, and supported by the European Commission. The purpose of the meeting was to call for a global goal of national responsibility in satisfying organ donation and transplantation needs, with sufficiency based on resources obtained within a country for that country and through regulated and ethical regional or international cooperation, when needed. The concept of a national responsibility encompasses the following features: (1) action should begin locally (not precluding international cooperation); (2) strategies should be targeted to decrease the transplantation needs of a population and increasing organ availability, and should enhance cooperation between stakeholders involved; (3) these strategies must be based on solid ethical principles: solidarity, voluntary donation, and non-commercialization (1); and (4) strategies should be tailored to the local realities. The Third WHO Global Consultation carries forward the principles laid out in the WHO Guiding Principles for Human Cell, Tissue and Organ Transplantation, and the Declaration of Istanbul on Organ Trafficking and Transplant Tourism (1, 2). The WHO Guiding Principles articulate the importance of pursuing national or subregional self-sufficiency in organs for transplantation, in particular through increased efforts to promote donation after death. The Declaration of Istanbul further states that Jurisdictions, countries and regions should strive to achieve self-sufficiency in organ donation by providing a sufficient number of organs for residents in need from within the country or through regional cooperation. The goal of the Madrid consultation was to confront the self-sufficiency paradigm from a practical perspective, developing a comprehensive strategic framework for policy and practice directed at the global challenges of a shortage of organs for transplantation and unmet patient needs. Therefore, the Madrid Resolution expresses both a pledge to progress in satisfying organ donation and transplantation needs, and a roadmap of how this may be achieved. It was the intent that the consultation process should be comprehensive and holistic, encompassing different perspectives studied and discussed during the meeting. Eight different working groups were convened, with group members chosen to represent a variety of different clinical experiences and geographical regions, and to provide an interdisciplinary understanding of the issues. The eight groups identified specific goals and challenges, and proposed solutions and recommendations with respect to the following topics: 1. Assessing needs for transplantation 2. System requirements 3. Meeting needs through donation 4. Monitoring outcomes 5. Fostering professional ownership in the emergency department (ED) and intensive care unit (ICU) 6. The role of public health and society 7. Ethics 8. Measuring progress Each group was led by three individuals, who in advance of the meeting, worked together to guide the preparation of a draft document for discussion and refinement during the meeting. The outcomes of the working groups were also discussed in a plenary session. The final eight documents produced by the working groups complete the Madrid Resolution on Organ Donation and Transplantation and are based on a large body of evidence collected by participants before the consultation and reflecting their particular experiences representing 68 nations. The Madrid Resolution identifies the common challenges faced by both developing and developed countries, and the unique issues of particular societies and regions, and provides a diverse body of recommendations to governments, international organizations, and healthcare professionals regarding how to successfully meet the needs of patients. This document represents an immediate resource for policy makers and guide for practical initiatives. It is hoped that the Madrid Resolution will also inspire new work in this emerging and important field. The Resolution Meeting the needs of patients with respect to organ donation and transplantation is a national responsibility that should be met primarily through a country s own resources, with specific regulated and ethical regional or international cooperation when appropriate. National accountabilities can be broadly defined as the creation of a national planning context for chronic diseases treatable through organ transplantation that encompasses capacity control, regulatory control, and determination of the appropriate ethical environments. 1. National capacity control involves: (a) development of adequate and appropriate healthcare infrastructure and workforce development, consistent with development level and economic capacity; (b) adequate and appropriate financing of organ donation and transplantation programmes; and (c) management of need by investment in chronic disease prevention and vaccination. 2. National regulatory control consists of: (a) adequate legislation, covering declaration of death, organ procurement, fair and transparent allocation, consent, establishment of transplant organizations, penalty of organ trafficking, and commercialization; (b) regulation covering procedures for organ procurement, reimbursement, and allocation rules; (c) systems for monitoring and evaluation, including traceability and surveillance, and enabling evaluation of programme performance. 3. National authorities need to lead normative change, from organ donation as a right of donor and recipient to a responsibility across all levels of society, through education, unambiguous legislation, and committed support. Meeting needs of patients while avoiding the harms of transplant tourism and commercial donation

2 2011 Lippincott Williams & Wilkins S33 from living persons is an ethical imperative that relies on collective responsibility for donation after death, thereby contributing to the common good of transplantation for all. The WHO Guiding Principles for Human Cell, Tissue and Organ Transplantation provide the foundation for all efforts toward progress in meeting transplantation needs. Recommendations Informing The Resolution are the detailed recommendations of the eight working groups convened as a part of the Third WHO Global Consultation on organ donation and transplantation. The key recommendations of these working groups are as follows: Recommendations With Respect to Assessment of Transplantation Needs 1. True need for transplantation cannot be defined by availability of treatment. Instead assessment of need must be multifactorial and take into account: a. True incidence of end-stage organ failure, irrespective of treatment availability (in all age groups and for all organs). b. Complexity of conditions and the drivers of need. c. Nonmedical factors (e.g., economic, cultural, attitudinal, competing health priorities) that modify actual transplant needs within that setting. 2. Internationally consistent definitions, data, and tools need to be developed to accurately and comprehensively measure transplantation needs, thereby enabling a broader understanding of the issues facing different countries and facilitating the identification of global solutions. 3. An international registry of organ donation and transplantation should be established. The following nationallevel data should be made available for this purpose: a. National prevalence and incidence of end-stage organ failure and of diseases contributing to end-stage organ failure. b. Availability of treatment for end-stage organ failure (transplant and non-transplant). c. Waiting-list statistics, including true wait times. d. Progression and outcomes of organ dysfunction. e. Referral to organ replacement therapy (assist devises and transplantation). f. Time to workup, time to acceptance onto the waiting list, and time to receipt of an organ. 4. All countries should have the ability to assess their needs for transplantation. Governments should: a. Support the identification of organ failure or replacement needs as a priority for public health improvement; b. Allocate resources to registry development (operational and surveillance/monitoring) and furthermore create a registry for conditions leading to the need for organ transplantation; c. Invest in prevention programmes to reduce needs; d. Ensure the equity principle is applied in needs assessment; e. Create or support infrastructure and allotment of resources for all aspects of needs assessment. 5. With respect to needs assessment in transplantation, WHO should: a. Identify as a resolution that all countries shall have the ability to assess their needs for transplantation by 2020; b. Identify and outline the need for the use of a core minimum dataset by which international comparisons will become meaningful. 6. Professional societies and healthcare providers should: a. Ensure consistency of definitions and use of metrics with respect to registry data; b. Support identification of organ failure as a strategic priority; c. Foster international enquiry, collaboration, and development in the area of needs assessment; d. Promote and support education relating to needs assessment, including technical advice regarding methodologies, data interpretation, and applications; e. Promote scientific enquiry in the area of needs assessment, including validation studies; f. Ensure linkages with governmental agencies and policy makers to support translation of research. Recommendations With Respect to Systems and Organization 1. Clear and unambiguous legislative and regulatory frameworks are the foundation on which successful systems for organ donation and transplantation, based on ethical and transparent practices with respect to organ procurement, recovery, allocation and transplantation, are built. Governments should therefore: a. Enact transplantation legislation consistent with the WHO Guiding Principles. Legislation should address: Standards for determining and declaring death; Organ procurement from deceased and living persons; Fair and transparent allocation to wait-listed patients, based on medical criteria; Respect for the wishes of the deceased concerning consent; Establishment of transplant organizations; Prohibition of organ trafficking and commercialization. Governments should also: b. Incorporate donation and transplantation into national health policies as a priority; c. Support donation after death; d. Invest in basic infrastructure and professional training; e. Create a national waiting list and comprehensive registry of donors and recipients; f. Create the necessary systems for ongoing regulation and oversight to ensure transparency and facilitate review of progress and the implementation of new strategic policies; g. Lead public awareness of organ transplantation and commit to public education. 2. NTOs responsible for coordination and oversight, ethical practice, regulation, policy setting, maintenance of national data registries, and data protection are essential. Core functions are to include:

3 S34 Transplantation Volume 91, Number 11S, June 15, 2011 a. Surveillance of practices, standards, and outcomes in organ donation and transplantation; b. Assurance of ethically proper organ procurement and allocation, transparency of all organ donation and transplantation processes, and traceability of donated human materials; c. Standardization of procedures and performance management of Organ Procurement Organizations (OPOs), related non-government organizations (NGOs), individual transplantation centers, ethics committees, and transplant teams; d. Regulation and management of the reimbursement of reasonable and verifiable expenses incurred by the living donor, and reimbursement of hospitals that incur costs in donating or procuring organs; e. Oversight of the division of responsibilities across all organizations involved in organ donation and transplantation; f. Public endorsement of organ donation and transplantation and support of the process with mass media education and promotion. 3. When organization is based on OPOs, these organizations manage procurement activities independently of hospital transplant units, subject to government approval and regulation. The nature of OPOs will vary according to different national requirements and realities, although the essential functions are the same in every setting, which are as follows: a. Surveillance and detection of possible/potential donors at every acute care hospital. b. Donor management for the recovery of viable organs. c. Coordination of procurement, through a designated Organ Procurement Coordinator (OPC). 4. Performance is dependent on successful integration and coordination across systems. All countries performing transplantation need to organize a unified coordination that regulates organ donation and transplantation processes. In addition, international coordination facilitates cross-border exchange of organs, information and research, and it is critical to combat organ trafficking and transplant tourism. Recommendations With Respect to Organ Donation 1. Countries and jurisdictions should aim to maximize donation from deceased persons, maximize the outcome from each deceased donor, and optimize results of transplantation. a. Donation from deceased persons is a requirement; transplantation activity cannot rely on living donors. b. Both donation after brain death (DBD) and donation after circulatory death (DCD) are to be considered. c. Countries should enable transplants from living donors, as complementary to donation from deceased persons, by providing appropriate ethical and legal frameworks and donor care. 2. Donation after death is a process, at any stage of which losses of potential donors may occur. Therefore, to maximize donation from deceased persons, an organizational approach should be adopted with explicitly defined actions, roles, and responsibilities across the entire process. The Critical Pathway for organ donation is to be considered a general framework of reference for systematizing the deceased donation process. The objectives of The Critical Pathway are as follows: a. To provide a common systematic approach to the process of donation from deceased persons, both for DBD and DCD. b. To create common triggers to facilitate the prospective identification and referral of the possible deceased organ donor and precipitate the deceased donation process. c. To provide common procedures to estimate the potential of organ donation from deceased persons and evaluate performance in the deceased donation process. 3. With respect to organ donation from deceased persons, governments should: a. Eliminate legislative impediments constraining the medicine and science of donation from deceased persons and organ transplantation; b. Provide adequate support (including financial support) for organ donation from deceased persons and transplantation programmes; c. Ensure equitable access to transplantation therapies and transparency of the system; d. Through a NTO (see Recommendations with respect to Systems and Organization, number 2) provide oversight and ensure the development and implementation of the following: The Critical Pathway; Protocols for all steps of the process of donation after death, especially timely identification and referral; Appointment of trained professionals, including donor coordinators, who are accountable for performance; A data registry for ongoing evaluation of donation processes, estimation of the potential of donation from deceased persons, evaluation of overall performance, identification of areas for improvement, and factors critical to success; Professional training and promotion of a national culture of donation. 4. With respect to donation from deceased persons, the WHO should: a. Promote the international implementation of The Critical Pathway; b. Monitor the collection of relevant data assessing performance in organ donation for international benchmarking; c. Foster regional cooperation in organ sharing that preserves equity between donor and recipient populations, and the efficient transplantation of otherwise discarded organs. 5. With respect to organ donation from deceased and living persons, healthcare professions should: a. Make every effort to maximize the number of organs recovered and transplanted; b. Support and promote DCD;

4 2011 Lippincott Williams & Wilkins S35 c. Present the option of donation from living persons to families, with all practices in the donation of organs from living persons consistent with the principles of The Declaration of Istanbul. Recommendations With Respect to Monitoring of Outcomes in the Pursuit of Self-Sufficiency 1. The purpose of registering data on transplant activities and outcomes is to identify areas in need of improvement; to enable system transparency, equity, and compliance; and to monitor system improvement both longitudinally within a given system and between systems through international benchmarking. Registries should be not only concerned with donors and recipients but also with infrastructure availability. They are a tool for quality assurance and policy making, and registry data may furthermore be used to raise awareness of the need for organ donation among the lay public and policy makers. 2. In all countries/regions, data should ideally be collected in the following areas: a. Available infrastructure (hospital and organizational); b. Regulatory oversight and health policy; c. Current and likely future needs for transplantation; d. Access to the waiting list and to transplantation; e. Waiting-list outcomes; f. Travel for transplantation and transplant tourism; g. Organ donation from deceased persons; h. Organ donation from living persons; and i. Outcomes of transplantation (patient and graft survival). 3. Two complementary data collection systems are proposed: a. A national/regional system, which has operational functions (allocation) and monitoring and evaluation. b. An international system with a global perspective, under an International Data Group. The International Data Group would establish standardized definitions/ metrics, provide assistance to national/regional registries, facilitate comparisons between systems and international benchmarking, identify regions in need of data, guide individual nations and systems, and facilitate research into special patient groups where small patient numbers would otherwise be restrictive. 4. With respect to monitoring, governments should: a. Support national/regional registries with infrastructure and human resources; b. Establish responsibility for operation and governance of this registry; c. Facilitate cooperation between government and NGOs in monitoring outcomes and disseminating information to the scientific community, the public, and policy makers; and d. Use registry data to assess the impact of policy change and inform the need and direction of new legislation and policy. 5 Professionals and professional societies should: a. Provide content expertise; b. Cooperate on the consistency of data elements across the continuum of organ failure (i.e., chronic kidney disease, dialysis, and transplantation); and c. Facilitate development of an International Data Group for the ongoing collection of data that will empower individual countries and regions in the pursuit of self-sufficiency. Recommendations With Respect to Fostering Emergency and Intensive Care Department Professional Ownership of Organ Donation 1. Organ donation is a different process than organ transplantation and requires different skills and personnel to maximize its potential. Possible and potential deceased donors are found in the ICUs and increasingly in EDs. Physicians and nurses involved in acute care need to be aware of their critical role in identifying possible and potential donors and to be engaged in the development of programmes for organ donation from deceased persons. Therefore, the pursuit of self-sufficiency requires ICU and ED doctors and nurses to: a. Be aware of the need for organ donation and therefore want to facilitate it; b. Know how to facilitate organ donation and have the educational, technical, legal and ethical tools to do so; c. Be supported by their colleagues, hospitals and health authorities in facilitating organ donation; d. Be recognized as experts in this area and in educating their colleagues; e. Take the lead in enabling their facility to provide this service, including appropriate counseling for families. 2. To foster professional ownership of self-sufficiency in the ED and ICU, governments should: a. Under legal, ethical, and medical frameworks for practice, include: Standards for determining death, enacted by the legislature, and accepted by the profession and public; Evidence-based tests and methods that physicians can readily use to apply these standards in the ED and ICU; Clear statements, at institutional and governmental levels, regarding the responsibility of various care providers to donors and recipients. b. Provide unambiguous guidance ensuring that individual medical staff involved in acute care are not personally or legally vulnerable when aiding the organ donation process. 3. Professional bodies should: a. Provide training and guidance for Emergency/Intensive Care nurses and physicians, covering: The need for organ donation and the importance of the role of acute care physicians and nurses; Identification of possible and potential donors; Death determination; Protocols on how treatment decisions (e.g., for patients with severe neurologic injuries) relate to donor status and to alternative (circulatory/respiratory and neurologic) bases for determining death; Protocols on how to manage the dying process for patients whose deaths will be determined on circulatory/ respiratory or neurological grounds, and on post-death maintenance of body;

5 S36 Transplantation Volume 91, Number 11S, June 15, 2011 How to make donation an understandable and acceptable choice for families of dying patients; Effective interaction with the OPO and transplantation team. b. Support the development of academic and scientific research activity in the emergency and intensive care communities to create a professional investment in the best practice approaches that emerge. 4. Hospitals should: a. Give local ED and ICU staff ownership of solving the problems and developing protocols for managing the care of potential donors; b. Identify individuals within the emergency or intensive care team who can act as role models or champions to increase the profile of organ donation within that facility and provide education to the team on all relevant issues; c. Appoint donor coordinators within hospitals to facilitate communications among emergency and intensive care staff, bereaved families and transplantation services; d. Include the possibility or potential for organ donation in every end-of-life care pathway in the ED/ICU; e. Improve the interface between the ED/ICU and the local transplant team and responsible National Authority; f. Identify strategies to minimize the effects of lack of resources on the conversion of potential donors to actual donors; g. Audit outcomes of the donation process within each facility to allow identification of potential areas for improvement, set achievable targets, and formally recognize excellence. Recommendations With Respect to the Role of Public Health and Society 1. Roles for public health in the pursuit of self-sufficiency include: a. Prevention of the frequent causes of end-stage organ failure (diabetes, hypertension, alcohol abuse, hepatitis B virus [HBV], hepatitis C virus [HCV], coronary artery disease [CAD], and chronic obstructive pulmonary disease [COPD]), including primary, secondary, and tertiary prevention; b. Promotion of organ donation among health professionals and the general public; c. Development of effective healthcare systems capable of supporting efficient organ procurement, equitable allocation, safety and quality, and national disease prevention programmes. 2. The act of donation is itself an individual decision that interacts with the social setting and the institutional and regulatory framework into which an individual is embedded. Family refusal, together with failure to identify possible and potential donors, is the most significant impediment to increase rates of donation. Roles for society in the pursuit of self-sufficiency include: a. Public education efforts to counter poor awareness, distrust of medicine, and misconceptions about donation and transplantation, while instilling notions of reciprocity, solidarity, and building public willingness to support organ donation; b. Community funding for donation and transplantation through public finance and charitable sources. 3. Recommendations for public health: a. Reduce demand for transplantation by prevention of major risk factors for end-stage organ failure and by developing healthcare systems able to effectively and equitably meet the challenges of chronic diseases, particularly diabetes and hypertension; b. Develop awareness and increased willingness of medical professionals to be involved in the donation and transplantation process, encourage a stakeholder role for ICU/ED physicians, and develop specific education programmes for primary care physicians, nurses, medical students, and allied health professionals; c. Develop culturally sensitive awareness programmes, using public health methodologies to promote trust and strengthen commitment to organ and tissue donation in the community; d. Increase the efficiency of healthcare systems and transplant programmes by using private and non-government sources of funding as appropriate, and developing synergies between the government and NGOs. 4. Recommendations for society: a. Provide regular and consistent normative change communication programmes and culturally sensitive awareness programmes directed at community and faith-based organizations; b. Provide public recognition of donors and their families and actively manage adverse publicity; c. Ensure all aspects of donation and transplantation are transparent to the public, and develop educational programmes to dispel myths and misconceptions, taking into account the range of community beliefs and values. 5. In settings where resource limitations and health sector development constrain the development of organ donation and transplantation programmes, the prevention of end-stage organ failure, within the context of wider public health goals, is crucial to self-sufficiency. In such settings, delivery of transplantation therapy may be approached through locally relevant approaches to financing, using both private and non-governmental sources of funding, and developing synergies between governments, NGOs, and charities. Recommendations With Respect to Ethics in the Pursuit of Self-Sufficiency 1. Self-sufficiency must be supported by normative change, reframing organ donation from a matter of the rights of donor and recipient, to a responsibility functioning at all levels of society (individual, government, professional, etc). The self-sufficiency paradigm is based on three main ethical premises: a. The human right to health requires that governments engage in prevention and providing transplantation services. The responsible administration of scarce resources such as organs also encompasses concerted ac-

6 2011 Lippincott Williams & Wilkins S37 tions directed toward prevention of end-stage organ failure. b. Organs should be understood as a social resource; therefore, equity should govern both procurement and allocation. c. Organ donation should be perceived as a civic responsibility toward fellow citizens; in contrast, organ markets and transplant tourism lead to morally unacceptable coercion and exploitation. 2. In accordance with The Declaration of Istanbul and the WHO Guiding Principles, self-sufficiency promotes the following ethical principles: a. Minimizing harm/reducing suffering both decreasing need for transplantation and efforts to maximize the number of organ available for transplantation are emphasized. b. Justice an equitable distribution of benefit and burden and the elimination of exploitation are central to the self-sufficiency paradigm. c. Respect for persons self-sufficiency avoids undue incentives while appealing to solidarity and civic responsibilities toward the community. 3. With respect to ethics and self-sufficiency: a. Governments/health authorities should be accountable for the ethical integrity of organ donation and transplantation systems; b. Health professionals should receive training in the ethical aspects of organ transplantation and be vigilant concerning unethical or illegal behavior, and professional societies should foster enquiry on questions of culture, values, and ethics relating to selfsufficiency; c. Civil society should establish an ethos of social responsibility and solidarity in meeting the community s transplantation needs through participation in donation after death, necessitating the engagement of community- and faith-based organizations and NGOs. Overall Recommendations With Respect to Effective Progress in the Pursuit of Self-Sufficiency 1. The capability of individual countries/regions to meet transplantation needs is determined by economic resources, systems development, and existing health priorities. The minimum level of transplantation capability is defined as the presence of a few medical professionals who have the capability to provide appropriate presurgical and postsurgical management of transplant recipients and living donors in a context of no local transplantation activity; maximum capability is defined as a comprehensive multiorgan transplant programme that provides an adequate supply of transplantable organs to meet the needs of the population. By defining successive levels of capability, the inclusive nature of the self-sufficiency paradigm is reinforced, and it is possible to describe a framework for evolution and achievement in organ donation and transplantation that is adaptable to all contexts. 2. The pursuit of self-sufficiency involves the development and implementation of strategies aimed at increasing national/regional transplantation capabilities to progress from one level of capability to the next, in a manner that is consistent with local realties and does not distort existing health priorities. Countries/regions evolve toward greater self-sufficiency in organ donation and transplantation through incremental achievements in each of the following domains: a. Resources and professional development for donation and coordination; b. Legal and regulatory frameworks; c. Resources and professional development for transplant services; d. Government and other resources; e. Community involvement; f. Assessment and minimization need for organs. 3. To enable evolution and achievement in transplantation capability, Governments should: a. Acknowledge their responsibilities in managing endstage organ failure from prevention to treatment in their population and designate a focal point/coordinating authority; b. Derive an integrated strategy for the care of patients with end-stage organ failure, from prevention of organ disease and organ failure to replacement therapies including transplantation, to optimize the use of resources; c. Include the elements of organ donation and transplantation in their national health plan and assess their own level of transplantation capability; d. Allocate resources, develop infrastructure, and strengthen health systems to support the achievement of these goals; e. Report national data on organ donation and transplantation activities to the Global Observatory on Donation and Transplantation (GODT); f. Participate in public education and engage professionals, professional societies, NGOs, and the community; g. Foster regional and international cooperation in the pursuit of these goals. 4. To support national/regional efforts to pursue selfsufficiency, WHO should: a. Urge MS to adopt and implement the principles of the Madrid Resolution; b. Urge MS to self-assess their level of transplantation capability, to aid the identification of areas for improvement; c. Monitor progress in levels of achievement in the pursuit of self-sufficiency across MS: d. Align the range of quantifiable indicators collected by the GODT to the framework of the Madrid Resolution; e. Develop international standards, guidelines, and tools, in collaboration with professional organizations, for the advancement of transplantation policy and practice; 5. To support national/regional efforts to pursue selfsufficiency, professionals and professional societies should: a. Acknowledge their responsibilities with respect to their own professional development, adoption of ethical

7 S38 Transplantation Volume 91, Number 11S, June 15, 2011 practices, maintenance of standards, and training for donation and procurement; b. International societies should support the establishment and work of the relevant national societies to further their missions with respect to organ donation and transplantation; c. Provide professional advice to MS and assistance for the development of standards for accreditation and quality assurance; d. Participate in professional and public education and engage other professionals and the public in the advancement of organ donation and transplantation; e. Encourage research, especially clinical research directed at maximizing benefits, minimizing costs, and optimizing resource allocation in organ donation and transplantation. CONCLUSIONS The Madrid Resolution on Organ Donation and Transplantation recognizes that donation and transplantation are more than a good gesture and a medical service. For patient needs to be met, all citizens and residents must be involved. From a public perspective, national attempts to meet patient needs rely on a communal appreciation of the value of organ donation. The concept of donating human body parts to save the life of another as a civic gesture is one that should be taught at school as a part of health education along with promotion of healthy life style. The organizational requirements and allocation of resources necessary to maximize donation from deceased donors and ensure equitable access to transplantation services, and the implementation of preventive interventions to alleviate needs for transplants, mandate the active commitment of Government. The benefits to be gained extend way beyond the successful transplantation of patients. The pursuit of the goal of ensuring a national responsibility in satisfying the donation and transplantation needs of a given population, outlined in the Madrid Declaration, has the capacity to strengthen the public health and community values of reciprocity and solidarity, while it is the only safe guard against the temptation of yielding to trade in human organs. REFERENCES 1. Steering committee of the Istanbul Summit. Organ trafficking and transplant tourism and commercialism. The Declaration of Istanbul. Lancet, 2008; 372: 5. Available at: http// 2. WHO Guiding Principles; WHA 63.22/2010 Available at: